FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
160177–160200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1982
CARDIOCASSETTE II #363
K821453 · DSH
Birtcher Corp.
Cardiovascular · 11d
Cleared May 24, 1982
MICROLYTE
K820541 · JJF
Kone Instruments, Inc.
Chemistry · 83d
Cleared May 24, 1982
SCIMED MODEL SC 3000
K820954 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared May 24, 1982
CARE MODEL IP 4500 AUTO SCANNERR
K821015 · DRT
Care Monitoring Systems
Cardiovascular · 42d
Cleared May 24, 1982
CONPHAR
K821077 · EGN
Conphar, Inc.
Dental · 35d
Cleared May 24, 1982
HAND KERATOSCOPE
K821080 · HLR
Medical Equipment Designs, Inc.
Ophthalmic · 35d
Cleared May 24, 1982
DENTAL FLOSS HOLDER
K821155 · JES
Eric L. Smith
Dental · 28d
Cleared May 24, 1982
SONIC MODEL 8711 HEARING AID
K821165 · ESD
Spec Systems, Inc.
Ear, Nose, Throat · 28d
Cleared May 24, 1982
DISPOSABLE URINARY LEGBAG W/STRAP
K821168 · KNX
Medical Marketing Group
Gastroenterology & Urology · 27d
Cleared May 24, 1982
SPIN CHEM REAGENTS & STANDARDS
K821184 · JIY
Smithkline Diagnostics, Inc.
Chemistry · 27d
Cleared May 24, 1982
HEMOGLOBIN REAGENT SET
K821202 · GKK
Omega Medical Electronics
Hematology · 27d
Cleared May 24, 1982
GOLDSMITH & REVERE TENARY ALLOY
K821222 · EJJ
Goldsmith & Revere, Inc.
Dental · 27d
Cleared May 24, 1982
PEDERSON VAGINAL SPECULA
K821291 · HDF
Conphar, Inc.
Obstetrics & Gynecology · 20d
Cleared May 24, 1982
GRAVES SPECULA
K821297 · HDF
Conphar, Inc.
Obstetrics & Gynecology · 20d
Cleared May 24, 1982
PROLACTIN (125-I) RADIOIMMUNOASSAY KIT
K821305 · CFT
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared May 24, 1982
DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM
K821315 · CDT
The Dow Chemical Co.
Chemistry · 20d
Cleared May 24, 1982
OMED FABRIC INSTRUMENT COVERS-RADIOPAQ
K821334
Omega-Med Intl., Inc.
General & Plastic Surgery · 19d
Cleared May 24, 1982
ADULT INCONTINET BRIEF
K821397 · EYQ
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 13d
Cleared May 24, 1982
PHENOBARBITAL FLUORESCENT IMMUNO
K821408 · LET
American Diagnostic Corp.
Toxicology · 13d
Cleared May 24, 1982
CORPAK-ENTERAL FEEDING CONTAINER
K821409 · KNT
Corpak Co.
Gastroenterology & Urology · 10d
Cleared May 24, 1982
CORPAK-MONITOR ENTERAL FEEDING CONTAIN
K821410 · KNT
Corpak Co.
Gastroenterology & Urology · 10d
Cleared May 21, 1982
KEYMED KEY VAC SUCTION PUMP
K820739 · BTA
Keymed, Inc.
General & Plastic Surgery · 64d
Cleared May 21, 1982
LESSER METATARSAL PHALANG. JOINT PROSTH
K820813 · KWH
Sutter Biomedical, Inc.
Orthopedic · 59d
Cleared May 21, 1982
GORE-TEX PERITONEAL CATHETERR
K820909 · FJS
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 50d